Antiseptic Skin Cleanser

Description

Walgreens offers a range of dye-free antiseptic skin cleansers containing Chlorhexidine Gluconate 4% solution, which serves as an antiseptic and antimicrobial agent. The product is available in multiple formulations: an 8 FL OZ (237 mL) bottle, a 16 FL OZ (473 mL) bottle, and an 18 FL OZ (532 mL) foaming skin cleanser. Each formulation is designed for effective skin cleansing and is comparable to the active ingredient found in Hibiclens®. All products are tamper evident, with a warning to not use if the safety seal is broken or missing. The National Drug Code (NDC) for the 8 FL OZ formulation is 0363-1061-08, for the 16 FL OZ formulation is 0363-1061-16, and for the 18 FL OZ foaming cleanser is 0363-1061-184WA18FM1061LBLB.

Uses and Indications

This drug is indicated for use in healthcare personnel handwashing to help reduce bacteria that may potentially cause disease. It is also indicated for skin wound care and general skin cleansing.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare personnel should begin by wetting their hands with water. Approximately 5 mL of the product should be dispensed into cupped hands, followed by vigorous washing for a duration of about 15 seconds. After washing, hands must be rinsed thoroughly and dried.

For skin wound and normal skin cleansing, the area to be cleaned should first be thoroughly rinsed with water. The minimum amount of product necessary to adequately cover the skin or wound area should then be applied, followed by gentle washing. The area must be rinsed thoroughly once more to ensure complete removal of the product.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation. Additionally, the product should not be applied in contact with the meninges due to the potential for serious adverse effects. It is also contraindicated for use in the genital area to prevent irritation or other complications.

Warnings and Precautions

For external use only. This product carries a significant risk of causing severe allergic reactions. Symptoms indicative of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

General precautions must be observed to ensure safe application. The product should be kept away from the eyes, ears, and mouth, as contact with these areas may result in serious and permanent eye injury or potential deafness if introduced into the middle ear through perforated eardrums. Should the solution inadvertently contact these sensitive areas, it is essential to rinse thoroughly and promptly with water.

Wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product. Additionally, repeated cleansing of large body areas is discouraged unless specifically advised by a healthcare provider.

Healthcare professionals should instruct patients to stop using the product and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious underlying condition.

In cases of ingestion, immediate medical attention is required. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients using this product may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, which may manifest as symptoms including wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance. It is crucial to note that this product should not be used by individuals who are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation.

In addition to allergic reactions, there are specific warnings regarding the use of this product. It should not be applied in contact with the meninges or in the genital area. Care should be taken to avoid contact with the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or potential deafness if the solution is instilled in the middle ear through perforated eardrums. Should the solution come into contact with these sensitive areas, it is imperative to rinse thoroughly with water.

Patients should also be cautious when using this product on wounds. It is not recommended for routine treatment of wounds that extend beyond the superficial layers of the skin. Furthermore, repeated general skin cleansing of large body areas should only be performed under the guidance of a healthcare provider.

If patients experience irritation, sensitization, or any signs of an allergic reaction while using this product, they should stop use and consult a healthcare professional, as these symptoms may indicate a serious condition.

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, including chlorine bleach, leading to staining. It is advised to rinse the skin thoroughly after use and to utilize only non-chlorine detergents to prevent this interaction.

Packaging & NDC

Below are the non-prescription pack sizes of Antiseptic Skin Cleanser (chlorhexidine gluconate 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly premature infants and those under 2 months of age, should use this product with caution. There is a risk of irritation or chemical burns associated with its use in this population. Healthcare professionals are advised to closely monitor these patients to mitigate potential adverse effects.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of chlorhexidine gluconate during pregnancy has not been established. Currently, there are no specific contraindications listed for its use in pregnant patients. Additionally, the prescribing information does not provide any data regarding potential risks to the fetus associated with the use of chlorhexidine gluconate during pregnancy. There are no recommended dosage modifications for pregnant individuals, nor are there any special precautions specified for the use of chlorhexidine gluconate in this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this agent in pregnant patients.

Lactation

Lactating mothers should use this product with caution, particularly in the case of premature infants or those under 2 months of age. There is a risk that the product may cause irritation or chemical burns in breastfed infants. Therefore, careful consideration and monitoring are advised when administering this product to lactating mothers who are nursing young infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports of allergic reactions, including anaphylaxis, have been documented, alongside other serious allergic manifestations such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash.

Additionally, cases of chemical burns have been reported, particularly among premature infants and infants under 2 months of age. There have also been instances of eye injury noted when the solution has come into contact with the eyes.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is essential to inform patients not to use the product if they have a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation.

Patients should be cautioned against using the product in contact with the meninges or in the genital area. They must be instructed to discontinue use and consult a healthcare professional if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition.

When using this product, patients should be reminded to keep it away from the eyes, ears, and mouth, as contact with these areas may lead to serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these sensitive areas, patients should rinse thoroughly and promptly with water.

Healthcare providers should also inform patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Additionally, repeated general skin cleansing of large body areas should only be performed when specifically advised by a healthcare provider.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Antiseptic Skin Cleanser, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)